July 23 Quick Takes: Priority Review for Aurinia; plus Jazz, CymaBay, Biogen, Vertex, Grünenthal, Mesoblast, BMS and Genfit
Priority Review for Aurinia’s lupus nephritis therapy
FDA accepted and granted Priority Review to an NDA for voclosporin from Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH; TSX:AUP) to treat lupus nephritis. The PDUFA date for the immune-suppressing, IL-2-blocking calcineurin inhibitor is in January.
FDA approves Jazz’s narcolepsy therapy
FDA approved Xywav from Jazz Pharmaceuticals plc (NASDAQ:JAZZ) to treat cataplexy or excessive daytime sleepiness (EDS) in narcolepsy patients seven years of age and older. The GABA B receptor modulator is an oral solution containing a mixture of oxybate salts with 92% less sodium than the company’s Xyrem sodium oxybate. Jazz is also evaluating Xywav as a treatment for idiopathic hypersomnia in adults...